1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[3-substituted-heteroalkyl]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

14 - 21 Dec 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS GmBH, Med. Versuchstierzuchten KG, D-7964 Kisslegg
- Age at study initiation: adult, age not specified
- Weight at study initiation: 2 to 3 Kg
- Housing: individually in metal cages
- Diet: standard rabbit food NAFAG, No. 814 Gossau SG, ad libitum
- Water: ad libitum.
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin.

Vehicle:

other: polyethylene glycol (PEG 400) + Saline (70:30)

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g of test material
- Application: gauze patches of 2.5 x 2.5 cm laden with the test material

VEHICLE
- Concentration: 50%

Duration of treatment / exposure:

The dressings were removed after a 24 hour application.

Observation period:

7 days

Number of animals:

3 male and 3 female

Details on study design:

TEST SITE
- Area of exposure: before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland.
- Type of wrap if used: the patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM
Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.625

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Other effects:

One animal died after 6 days. No symptoms had been observed previously.

Any other information on results incl. tables

Intact skin reactions

Animal/sex	Reaction	24 hrs	48 hrs	72 hrs	4 days	7 days	Mean 24, 48 and 72 hrs
144	Erythema	2	1	0	0	0	0.75
145	Erythema	2	1	1	1	0	1.25
146	Erythema	2	1	0	0	0	0.75
147	Erythema	1	1	1	0	/	0.75
148	Erythema	1	0	0	0	0	0.25
149	Erythema	0	0	0	0	0	0.00
144	Oedema	2	1	0	0	0	0.75
145	Oedema	1	1	0	0	0	0.50
146	Oedema	2	1	0	0	0	0.75
147	Oedema	0	0	0	0	/	0.00
148	Oedema	0	0	0	0	0	0.00
149	Oedema	0	0	0	0	0	0.00

Abraded skin reactions

Animal/sex	Reaction	24 hrs	48 hrs	72 hrs	4 days	7 days	Mean 24, 48 and 72 hrs
144	Erythema	2	1	1	0	0	1.00
145	Erythema	2	2	1	1	0	1.50
146	Erythema	2	1	0	0	0	0.75
147	Erythema	2	2	1	1	/	1.50
148	Erythema	1	0	0	0	0	0.25
149	Erythema	1	0	0	0	0	0.25
144	Oedema	2	1	0	0	0	0.75
145	Oedema	1	0	0	0	0	0.25
146	Oedema	1	1	0	0	0	0.50
147	Oedema	2	1	1	1	/	1.25
148	Oedema	0	0	0	0	0	0.00
149	Oedema	0	0	0	0	0	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

Method

The skin irritation potential was tested in New Zealand White rabbits. The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Results

Under the conditions of the present experiment the test compound was found to cause a slight irritation when applied to intact and abraded rabbit skin. One animal died after 6 days.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results according to the CLP Regulation (1272/2008), because the raw tables are included into the study report. Only the intact skin reactions were considered.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).